News

The ECA regularly provides evaluations of the FDA Warning Letters per fiscal year. In 6th place in the fiscal year 2022 (Oct. 2021 - Sept. 2022) are deficiencies regarding the topic of cleaning/cleaning validation. What was found?

Equipment qualification is often complicated, expensive and time-consuming. ECA´s Good Practice Guide "Integrated Qualification and Validation - a guide to effective qualification and validation based on Customer - Supplier Partnership" provides practical advice for leveraging equipment qualification. The guide is in compliance with EU and US regulations and takes into account standard recommendations as those in ASTM E2500.

Bracketing approaches are certainly allowed in the context of cleaning validation. First, for the products themselves, so that a "worst case" substance can be used for validation, second, for devices of the same design, the effort can be reduced by bracketing. In this way, a device can be selected. So how to define these "worst cases"? Read more here about FDA's view on this.

In the GMP rules there are many undefined terms, such as regular, adequate, etc. Inspection reports that interpret these undefined legal terms sometimes help here. In this case it is about insufficient process validation. What happened?